RecruitingPhase 1NCT06522932

PET Imaging Study of 64Cu-GRIP B for Patients Receiving CD19-directed CAR-T Therapy

A Phase I/Ib PET Imaging Study of 64Cu-GRIP B, a Radiotracer Targeting Granzyme B, in Patients Receiving CD19-directed CAR-T Therapy

Sponsor

Michael Randall

Enrollment

32 participants

Start Date

Oct 23, 2024

Study Type

INTERVENTIONAL

Conditions

Non-Hodgkin Lymphoma

Summary

This is a phase I/Ib imaging study of granzyme B, 64-copper granzyme targeting restricted interaction peptide specific to family member B (64Cu-GRIP B) Positron Emission Tomography (PET) in patients with relapsed/refractory non-Hodgkin's lymphoma (NHL) receiving CD19-directed Chimeric antigen receptor T cells (CAR-T) therapy. The proposed study represents the first-ever lymphoma patient imaging studies with 64Cu-GRIP B PET. The tracer is designed to detect extracellular granzyme B as it is secreted by activated immune cells in the tumor microenvironment, which may highlight tumors that will exhibit a durable response to Cluster of Differentiation 19 (CD19)-directed CAR T-cell therapy.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is using a special radioactive imaging agent called 64Cu-GRIP B in PET scans to monitor how CAR-T cell therapy (a type of engineered immune cell treatment targeting CD19) distributes and works in people with non-Hodgkin lymphoma. **You may be eligible if...** - You are 18 or older - You have been diagnosed with relapsed or refractory non-Hodgkin lymphoma (confirmed by biopsy) that has had at least one prior treatment - You are scheduled to receive a commercially available CD19-targeting CAR-T cell therapy - You have a safely accessible tumor site for a biopsy after treatment - You are in reasonably good health (ECOG less than 2) - You are willing to use contraception during and for 1 month after the study **You may NOT be eligible if...** - You have a condition that would prevent you from following study procedures - You are pregnant (effects of the imaging agent on fetal development are unknown) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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